자체점검 도구 개발을 위한 지적사항 및 임상연구의 품질에 작용하는 요인 분석

Analysis of Indicated Points and Main Factors Affecting the Quality of Clinical Research for the Development of Internal Audit Tools

  • 장혜윤 (계명대학교 동산병원 임상연구보호센터) ;
  • 장정희 (계명대학교 동산병원 임상연구보호센터) ;
  • 이윤진 (계명대학교 동산병원 임상연구보호센터)
  • Hye Yun Jang (Human Research Protection Center, Keimyung University Dongsan Hospital) ;
  • Jung-Hee Jang (Human Research Protection Center, Keimyung University Dongsan Hospital) ;
  • Yoon Jin Lee (Human Research Protection Center, Keimyung University Dongsan Hospital)
  • 투고 : 2022.09.26
  • 심사 : 2022.11.18
  • 발행 : 2023.02.28

초록

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

키워드

참고문헌

  1. Ministry of Food and Drug Safety. Operational guideline of human research protection program [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2021 [cited 2022 Jun 24]. Available from: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=12203.
  2. Keimyung University Dongsan Hospital HRPP SOP Ver 1.0. Daegu (Korea): Keimyung University Dongsan Hospital; 2020.
  3. Regulation: bioethics and safety act [Internet]. Sejong (Korea): Ministry of Health and Welfare; 2021 Dec 30 [cited 2022 Jun 13]. Available from: https://www.law.go.kr/LSW/lsSc.do?dt=20201211&subMenuId=15&menuId=1&query=%EC%83%9D%EB%AA%85%EC%9C%A4%EB%A6%AC#undefined.
  4. Regulation: pharmaceutical affairs law [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2022 Jul 21 [cited 2022 Jun 13]. Available from: https://www.law.go.kr/LSW/lsSc.do?dt=20201211&subMenuId=15&menuId=1&query=%EC%83%9D%EB%AA%85%EC%9C%A4%EB%A6%AC#undefined.
  5. Regulation: regulations on medicines and safety [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2022 Jul 21 [cited 2022 Jul 31]. Available from: https://www.law.go.kr/LSW/admRulInfoP.do?admRulSeq=4372#J18:0.
  6. Regulation: medical appliances act [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2022 Jul 21 [cited 2022 Jul 30]. Available from: https://www.law.go.kr/LSW/lsSc.do?dt=20201211&query=%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95&subMenuId=15&menuId=1#undefined.
  7. Regulation: enforcement rules of the medical device act [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2022 Jul 21 [cited 2022 Jul 30]. Available from: https://www.law.go.kr/LSW/lsSc.do?dt=20201211&query=%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0%EB%B2%95&subMenuId=15&menuId=1#liBgcolor5.
  8. Kim MG. Regular inspection of clinical trials and the establishment of an 'Internal Audit' system are key [Internet]. Seoul (Korea): dailypharm; 2019 Jan 21 [cited 2022 Jun 15]. Available from: http://www.dailypharm.com/Users/News/NewsView.html?ID=248749&REFERER=NP.
  9. Cafiso VF. U.S. Food and Drug Administration: inspection and enforcement overview [Internet]. Sunnyvale (CA): Linkedin; 2020 Nov 24 [cited 2022 Jun 15]. Available from: https://www.linkedin.com/pulse/us-food-drug-administration-inspection-enforcementoverview-cafiso.
  10. Bang JH. Query format for collecting laboratory data in clinical trials [thesis]. Seoul (Korea): Kookmin University; 2009. p. 45.
  11. Kim CW. False clinical trial records 'cancel institutional designation' [Internet]. Seoul (Korea): newsmp; 2018 Jul 6 [cited 2022 Jun 16]. Available from: http://www.newsmp.com/news/articleView.html?idxno=184663.
  12. Regulation: Korea Good Clinical Practice, article 18 (recording and reporting) [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2022 Jul 21 [cited 2022 Jul 31]. Available from: https://www.law.go.kr/LSW/admRulInfoP.do?admRulSeq=4372#J18:0.
  13. Lim JS. The domestic CRO market has grown 14% on average over the past five years [Internet]. Seoul (Korea): bokuenews; 2019 Nov 7 [cited 2022 Jun 30]. Available from: http://www.bokuennews.com/news/article.html?no=182985.
  14. Lee EA. "CRO determines the success rate of new drug development... 'data quality' key" [Internet]. Seoul (Korea): Biospectator; 2017 Apr 17 [cited 2022 Jun 30]. Available from: http://www.biospectator.com/view/news_view.php?varAtcId=3105.